Trial Title:
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
NCT ID:
NCT05948865
Condition:
Cancer
Cancer, Lung
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Cancer
Non-Small Cell Lung Cancer
Solid Tumors
Metastatic
Advanced
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CPO301
Description:
Administered by intravenous injection
Arm group label:
Part A, Dose Escalation
Arm group label:
Part B, Dose Expansion
Other name:
SYS6010
Summary:
The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug
conjugate in adult patients with advanced or metastatic solid tumors.
The main questions it aims to answer are:
- To assess the safety and tolerability of CPO301 at increasing doses and determine
the dose to be used in the second part of the study (Part A)
- To assess the safety and tolerability of CPO301 at the dose determined to be safe
and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially
other tumor types (Part B)
- To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK)
- To evaluate if antibodies to the study drug develop (immunogenicity)
- To evaluate preliminary efficacy to the drug
- To correlate preliminary efficacy with mutations in a biomarker called EGFR
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive CPO301 by intravenous injection every 3
weeks until the study doctor determines study treatment should be stopped, based on
how well a participant is doing on treatment
- Be followed for progression every 3 months for up to 2 years
Detailed description:
This Phase 1 study is a multicenter, dose-escalating, dose-expansion, single agent,
2-part study conducted in patients with advanced or metastatic solid tumors who
progressed on ≥1 prior conventional systemic therapy or who were ineligible or intolerant
to standard treatment or had no or refused standard treatment.
Dose escalation (Part A) - Dose escalation will be guided by a modified 3+3 design to
determine the maximum tolerated dose (MTD) or recommended dose of CPO301 (also known as
SYS6010). Determination of dose-limiting toxicity (DLT) will be based on toxicity
observed during the DLT observation period (first 21 days [1 cycle]). Dose escalation
decisions are made based on the occurrence of DLT. MTD will be determined based on the
data of all enrolled participants. To better identify the MTD, one or more dose groups
may also be added beyond the planned maximum dose group (if determined to be safe), or
between the maximum escalation dose group and the next lower dose group for DLT
assessment. Intermediate dose groups and/or adjustment to the dosing frequency may be
made
Dose expansion (Part B) - Additional patients will be enrolled at the recommended dose
determined in the dose escalation stage. An additional tumor cohort may be added based on
data observed in Part A.
Criteria for eligibility:
Criteria:
Major Inclusion Criteria:
- Age ≥18 years
- Patients with histologically confirmed locally advanced or metastatic solid tumors
who have disease progression, intolerance to prior therapy, are ineligible for
available therapies, or refuse standard of care therapy in the metastatic setting.
- In Part A, patients with solid tumors including but not limited to NSCLC
(adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type
colorectal cancer, and head & neck cancer based on previous biopsy result.
- In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR
mutations based on previous biopsy result and Cohort 2 will be patients with other
cancer(s) suggested to have sensitivity to CPO301 in Part A.
- At least 1 measurable target lesion present and documented by CT or MRI according to
RECIST v1.1
- ECOG performance status 0 or 1 at screening
- Life expectancy >12 weeks
Major Exclusion Criteria:
- Known, active, or uncontrolled central nervous system (CNS) metastasis or
carcinomatous meningitis.
- Has AEs due to previous anti-tumor treatments not recovered to ≤Grade 1 (except for
alopecia; some tolerable chronic toxicities of Grade 2 may be excluded after
consultation with the sponsor, as judged by the investigator) according to NCI-CTCAE
v5.0.
- Any serious and/or uncontrolled concurrent illness that may interfere with study
participation
Prior therapy
- Received other investigational drugs or treatments within 4 weeks before the first
dose of the investigational drug in the study
- The time interval between the latest anti-tumor treatment and the first dose of the
investigational drug meets the following requirements: Have received anti-tumor
treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and
other clinical investigational drugs within 4 weeks before the first dose of the
investigational drug; have received oral fluoropyrimidines, small molecule targeted
drugs within 2 weeks before the first dose of the investigational drug; have
received palliative radiotherapy or local therapy within 2 weeks before the first
dose of investigational drug.
- Had major surgery within 4 weeks before the first dose of the investigational drug
in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jacob Thomas, MD
Email:
Principal Investigator
Facility:
Name:
Hoag Memorial Hospital Presbyterian
Address:
City:
Newport Beach
Zip:
92658
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Carlos R Becerra, MD
Email:
Principal Investigator
Facility:
Name:
UCLA Hematology/Oncology - Santa Monica
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Lee S. Rosen, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute (SCRI) at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gerald Falchook, MD, MS
Email:
Principal Investigator
Facility:
Name:
AdventHealth Cancer Institute
Address:
City:
Celebration
Zip:
34747
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Guru P. Sonpavde, MD
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Manish Patel, MD
Email:
Principal Investigator
Facility:
Name:
Dartmouth Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Konstantin Dragnev, MD
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Anshu Giri, MD
Email:
Principal Investigator
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Melissa L Johnson, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alex Spira, MD
Email:
Principal Investigator
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Quincy Chu, MD
Email:
Principal Investigator
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Rosalyn Juergens, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Cancer Centre - University Health Network
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Laswson Eng, MD
Email:
Principal Investigator
Start date:
June 6, 2023
Completion date:
December 12, 2025
Lead sponsor:
Agency:
Conjupro Biotherapeutics, Inc.
Agency class:
Industry
Source:
Conjupro Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05948865
